SAN DIEGO, July 11, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that it will report second quarter 2025 financial results on Thursday, August 7, 2025 after the market closes. Company management will host a conference call at 4:30 p.m. ET to discuss financial results and provide a business update. Conference Call & Webcast Thursday, August 7 @ 4:30 p.m. ET Domestic: 1 833-470-1428International: 1 404-975-4839Access Code: 899803 Webcast: Participants can use the ...

Core Points - Crinetics Pharmaceuticals granted non-qualified stock option awards for 102,350 shares and restricted stock unit (RSU) awards for 77,875 shares to 46 new non-executive employees as part of the 2021 Employment Inducement Incentive Award Plan [1][2] - The stock options have an exercise price of $31.99 per share, equal to the closing price on July 10, 2025, and will vest over four years [2] - Crinetics Pharmaceuticals is focused on developing novel therapeutics for endocrine diseases and related tumors, with lead candidate paltusotine in clinical development for acromegaly and carcinoid syndrome [3] Summary by Category Stock Options and RSUs - The stock options and RSUs were granted as inducements for new employees under the 2021 Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4) [1][2] - Stock options will vest 25% after one year, with the remainder vesting in 36 equal monthly installments, contingent on continued employment [2] - RSUs will vest in equal annual installments over four years, also dependent on continued employment [2] Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company specializing in endocrine diseases and tumors [3] - The company’s lead candidate, paltusotine, is the first investigational oral selective somatostatin receptor type 2 nonpeptide agonist [3] - Other drug candidates in development include treatments for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered small molecules [3]

Core Insights - Crinetics Pharmaceuticals is set to present long-term efficacy and safety data for its investigational drug PALSONIFY (paltusotine) in acromegaly, demonstrating both biochemical and symptom control with a well-tolerated safety profile [1][2] - The company will also showcase Phase 2 trial results for atumelnant in congenital adrenal hyperplasia (CAH) and data from early-stage development programs in Graves' hyperthyroidism and orbitopathy at the Endocrine Society's Annual Meeting, ENDO 2025 [1][3] PALSONIFY Presentations - Four abstracts will report results from the PALSONIFY development program, including an oral presentation on long-term efficacy, safety, and symptom control in acromegaly patients switching from injectable somatostatin receptor ligands to once-daily oral PALSONIFY [2][4] - Three poster presentations will cover symptom stability in acromegaly, patient-reported outcomes from PATHFNDR-1 and PATHFNDR-2, and open-label extension data from PATHFNDR-2 [2] Atumelnant Presentations - Three abstracts will focus on atumelnant, including an oral presentation of Phase 2 trial results in CAH, highlighting reductions in adrenal volume and significant decreases in potent 11-oxygenated androgens [3][7] Early-Stage Pipeline - Crinetics will present new data from its early-stage pipeline, including findings related to CRN12755 for Graves' hyperthyroidism and orbitopathy [4][8] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors, with PALSONIFY and atumelnant as its lead candidates [11]

SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that on June 10, 2025, the Compensation Committee of the Board of Directors granted non-qualified stock option awards to purchase an aggregate of 74,000 shares of its common stock and granted an aggregate of 48,850 restricted stock unit (“RSU”) awards to 20 new non-executive employees, in each case, under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the “2021 In ...

Core Points - Crinetics Pharmaceuticals granted stock options and restricted stock units (RSUs) to new non-executive employees as part of its 2021 Employment Inducement Incentive Award Plan [1][2] - The stock options total 74,000 shares with an exercise price of $33.08, equal to the closing price on June 10, 2025, and will vest over four years [2] - The RSUs total 48,850 shares and will also vest over four years in equal annual installments [2] Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors [3] - The lead candidate, paltusotine, is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - Other drug candidates include Atumelnant, targeting congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered small molecules for various endocrine conditions [3]

Company Participation - Crinetics Pharmaceuticals will participate in the Jefferies Global Healthcare Conference from June 3-5, 2025 in New York, NY [1][2] Company Presentation Details - The company presentation is scheduled for Thursday, June 5, 2025, at 12:50 p.m. Eastern Time [2] Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors [3] - The lead candidate, paltusotine, is an investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist, currently in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - Atumelnant is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome [3] - All drug candidates are orally delivered, small molecule, new chemical entities resulting from in-house drug discovery efforts, targeting various endocrine conditions [3]

Core Insights - Crinetics Pharmaceuticals is presenting two abstracts at the AACE Annual Meeting 2025, highlighting the investigational candidate paltusotine's rapid and durable treatment effects in acromegaly patients and the significant symptom burden experienced by patients on standard treatments [1][2][3] Group 1: Paltusotine Development - Paltusotine is a once-daily oral medication that has shown promising results in controlling IGF-1 levels in surgically naïve acromegaly patients, with three out of four patients in one trial achieving IGF-1 normalization [4][10] - The company is preparing for a PDUFA action date of September 25 in the U.S., indicating potential regulatory approval for paltusotine [3][10] - Paltusotine is positioned as a viable first-line therapy for patients who cannot undergo surgery, with sustained IGF-1 control observed over 24 months in clinical trials [4][10] Group 2: Symptom Burden and Treatment Discontinuation - A study revealed that patients on long-acting injectable somatostatin analogs reported symptom exacerbations on 32% of days, leading to reduced quality of life and increased healthcare utilization [5][7] - A retrospective analysis indicated that 54% of acromegaly patients discontinued therapy, with only 20% remaining on their initial treatment, highlighting dissatisfaction with current injectable therapies [7] - The findings underscore the need for more effective treatments that provide consistent symptom control for acromegaly patients [5][7] Group 3: Atumelnant Development - Atumelnant, another investigational compound by Crinetics, is in development for ACTH-dependent Cushing's syndrome and has shown promising results in a Phase 2a study [11] - The compound is designed to selectively target the melanocortin type 2 receptor, potentially offering significant treatment benefits for patients with conditions related to excess ACTH [11]

Core Insights - Crinetics Pharmaceuticals is on track for the FDA review of paltusotine, with a PDUFA date set for September 25, 2025, for the treatment of acromegaly [5][6] - The company is initiating a Phase 3 study for atumelnant aimed at normalizing androstenedione levels in adults with congenital adrenal hyperplasia (CAH) [3][6] - Crinetics has a strong financial position with $1.3 billion in cash and equivalents as of March 31, 2025, expected to fund operations into 2029 [10][14] Regulatory and Clinical Developments - The FDA review process for paltusotine's New Drug Application (NDA) is progressing positively, with consistent engagement from the FDA [6] - The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for paltusotine, with a potential decision expected in the first half of 2026 [6] - The Phase 2 TouCAHn study of atumelnant in CAH has shown positive results, leading to the initiation of a Phase 3 CALM-CAH study [6][10] Financial Performance - Revenues for the first quarter of 2025 were $0.4 million, down from $0.6 million in the same period of 2024, primarily from a licensing agreement for paltusotine [10][14] - Research and development expenses increased to $76.2 million in Q1 2025 from $53.3 million in Q1 2024, driven by clinical program advancements [10][14] - The net loss for Q1 2025 was $96.8 million, compared to a net loss of $66.9 million in Q1 2024 [10][14] Upcoming Milestones - R&D Day is scheduled for June 26, 2025, to discuss early-stage pipeline strategies and data [3][10] - The company plans to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the second half of 2025 [10] - Initiation of the CALM-CAH Phase 3 study in adults and a Phase 2/3 study in pediatrics is expected in the second half of 2025 [10]

Company Overview - Crinetics Pharmaceuticals, Inc. is a clinical stage pharmaceutical company focused on discovering, developing, and commercializing novel therapeutics for endocrine diseases and endocrine-related tumors [3] - The company's lead development candidate, paltusotine, is an investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - Crinetics is also developing atumelnant, a first-in-class oral ACTH antagonist for treating congenital adrenal hyperplasia and Cushing's disease [3] - All drug candidates are orally delivered, small molecules resulting from in-house drug discovery efforts, targeting various endocrine conditions [3] Stock Option and RSU Awards - On April 10, 2025, the Compensation Committee granted non-qualified stock option awards to purchase 124,950 shares and 84,725 restricted stock unit (RSU) awards to 26 new non-executive employees under the 2021 Employment Inducement Incentive Award Plan [1][2] - The stock options have an exercise price of $26.85 per share, equal to the closing price of Crinetics' common stock on the same date [2] - The stock options will vest over four years, with 25% vesting on the one-year anniversary and the remainder vesting in 36 equal monthly installments, contingent on continued employment [2] - The RSUs will also vest over four years in equal annual installments starting on the one-year anniversary, subject to continued employment [2]